Overview
Vitamin D, in general, is a secosteroid generated in the skin when 7-dehydrocholesterol located there interacts with ultraviolet irradiation - like that commonly found in sunlight . Both the endogenous form of vitamin D (that results from 7-dehydrocholesterol transformation), vitamin D3 (cholecalciferol), and the plant-derived form, vitamin D2 (ergocalciferol), are considered the main forms of vitamin d and are found in various types of food for daily intake . Structurally, ergocalciferol differs from cholecalciferol in that it possesses a double bond between C22 and C23 and has an additional methyl group at C24 . Finally, ergocalciferol is pharmacologically less potent than cholecalciferol, which makes vitamin D3 the preferred agent for medical use . Appropriate levels of vitamin D must be upheld in the body in order to maintain calcium and phosphorus levels in a healthy physiologic range to sustain a variety of metabolic functions, transcription regulation, and bone metabolism . However, studies are also ongoing to determine whether or not cholecalciferol may also play certain roles in cancer, autoimmune disorders, cardiovascular disease, and other medical conditions that may be associated with vitamin D deficiency .
Indication
Cholecalciferol use is indicated for the treatment of specific medical conditions like refractory rickets (or vitamin D resistant rickets), hypoparathyroidism, and familial hypophosphatemia . Concurrently, as one of the most commonly utilized forms of vitamin D, cholecalciferol is also very frequently used as a supplement in individuals to maintain sufficient vitamin d levels in the body or to treat vitamin D deficiency, as well as various medical conditions that can be associated directly or indirectly with vitamin d insufficiency like osteoporosis and chronic kidney disease, among others .
Associated Conditions
- Bone Fractures
- Calcium and Vitamin D Deficiencies
- Deficiency of Vitamin D3
- Deficiency, Vitamin A
- Deficiency, Vitamin D
- Hip Fracture
- Hypoparathyroidism
- Hypophosphatemia, Familial
- Menopause
- Osteomalacia
- Osteoporosis
- Postmenopausal Osteoporosis
- Vertebral Fractures
- Vitamin D Resistant Rickets
- Vitamin Deficiency
- Severe Bone Resorption
- Spine fracture
Research Report
A Comprehensive Monograph on Cholecalciferol (Vitamin D3): From Molecular Structure to Clinical Application
Executive Summary
Cholecalciferol, commonly known as Vitamin D3, is a fat-soluble secosteroid that functions as a critical prohormone within the human body. While historically classified as a vitamin, its endogenous synthesis in the skin upon exposure to sunlight and its subsequent multi-organ activation into a potent hormone underscore its central role in a complex endocrine system. The primary and undisputed function of the Vitamin D system is the maintenance of calcium and phosphate homeostasis, which is essential for normal bone mineralization. Consequently, Cholecalciferol is a cornerstone therapy for the prevention and treatment of a range of skeletal disorders arising from its deficiency, including rickets in children, osteomalacia in adults, and as an adjunct with calcium for osteoporosis management.
A significant body of scientific evidence has established the clinical superiority of Cholecalciferol (D3) over its plant-derived counterpart, Ergocalciferol (D2). Studies consistently demonstrate that D3 is more potent and has a longer duration of action in raising and sustaining serum concentrations of 25-hydroxyvitamin D, the key indicator of vitamin D status. This has led to a broad consensus that Cholecalciferol should be the preferred form for both supplementation and therapeutic repletion.
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2020/09/03 | Phase 4 | Completed | Dr Mustahsin Khalil | ||
2020/09/02 | Phase 3 | Completed | Coordinación de Investigación en Salud, Mexico | ||
2020/08/06 | Phase 3 | Completed | Coordinación de Investigación en Salud, Mexico | ||
2020/07/27 | N/A | UNKNOWN | |||
2020/07/20 | Phase 3 | Completed | |||
2020/07/13 | Phase 3 | Completed | |||
2020/06/23 | Not Applicable | Completed | |||
2020/06/19 | Not Applicable | Completed | Baqiyatallah Medical Sciences University | ||
2020/06/02 | Phase 4 | Completed | Vitamin D Study Group | ||
2020/06/02 | Phase 2 | Completed | Heba Omara |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Oncora Pharma, LLC | 85477-606 | ORAL | 12.5 ug in 1 1 | 9/5/2025 | |
PureTek Corporation | 59088-017 | ORAL | 10 ug in 1 1 | 5/2/2025 | |
PureTek Corporation | 59088-162 | ORAL | 18.75 ug in 1 1 | 4/1/2024 | |
Avion Pharmaceuticals, LLC | 75854-315 | ORAL | 1000 [iU] in 1 1 | 1/7/2021 | |
BonGeo Pharmaceuticals, Inc. | 52796-177 | ORAL | 600 [iU] in 1 1 | 2/1/2024 | |
PureTek Corporation | 59088-108 | ORAL | 10 ug in 1 1 | 9/2/2022 | |
Bryant Ranch Prepack | 63629-1136 | ORAL | 400 [iU] in 1 1 | 12/30/2021 | |
Mission Pharmacal Company | 0178-0896 | ORAL | 200 [iU] in 1 1 | 8/13/2025 | |
Acella Pharmaceuticals, LLC | 42192-323 | ORAL | 400 [iU] in 1 1 | 9/11/2018 | |
PureTek Corporation | 59088-163 | ORAL | 125 ug in 1 1 | 1/11/2023 |
EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Prenatal Plus | 396774 | Medicine | A | 9/30/2022 | |
Eagle Clinical Tresos B Professional + | 489429 | Medicine | A | 5/21/2025 | |
VitalBoost | 485229 | Medicine | A | 4/4/2025 | |
Preconception Multi for Women | 476988 | Medicine | A | 1/29/2025 | |
Witsbb Vitamin A D softgel for Kids (clear) | 475060 | Medicine | A | 1/6/2025 | |
Nature’s Way Kids Smart Vita Gummies High Strength Calcium Vitamin K2+D3 | 473415 | Pharmacare Laboratories Pty Ltd | Medicine | A | 12/17/2024 |
Multi Vitamin | 472186 | Medicine | A | 12/9/2024 | |
Kidtal®️ Liquid Calcium | 468809 | Medicine | A | 11/15/2024 | |
Men`s Multi | 467971 | Medicine | A | 11/11/2024 | |
Skin + Gut | 464909 | Medicine | A | 10/18/2024 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
MEL-VITA-TAB | melaleuca of canada inc. | 02139693 | Tablet - Oral | 133 UNIT | 12/31/1996 |
VITA VIM WITH BETA CAROTENE-CAPLET | jamieson laboratories ltd | 02143453 | Tablet - Oral | 400 UNIT / TAB | 12/31/1995 |
FOR KIDS ONLY CHEWABLE MULTIVITAMINS - TAB | ksl pharmaceuticals | 02195771 | Tablet - Oral | 400 UNIT | 12/31/1996 |
CALTRATE 600 PLUS D - TABLET | whitehall-robins inc. | 02166984 | Tablet - Oral | 125 UNIT | 12/31/1985 |
CALCIUM-MAGNESIUM WITH K & ZN AND VITAMIN D3 | holista health (canada) inc. | 02155109 | Capsule - Oral | 100 UNIT | 8/15/1997 |
CHEWABLE CALCIUM 500 MG WITH VITAMIN D 200 IU | vita health products inc | 02248643 | Tablet - Oral | 200 UNIT | 1/10/2005 |
CHILDREN'S CHEWABLE WITH IRON | nutricorp international | 02247191 | Tablet - Oral | 400 UNIT | 9/30/2003 |
GERONTAL | le naturiste j.m.b. inc. | 02247038 | Tablet - Oral | 100 UNIT | 12/8/2003 |
CHILDRENS CHEWAB VITAMIN W CHEL MINERALS | anabolic laboratories inc. | 00526673 | Tablet - Oral | 400 UNIT | 12/31/1981 |
ENRICH CORE PACK FEMALE | enrich international | 02242544 | Capsule - Oral | 80 UNIT / CAP | N/A |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
VITAMINA D3 FARMASIERRA 1.000 U.I COMPRIMIDOS | Farmasierra Laboratorios S.L. | 86281 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
ACIDO ALENDRONICO/COLECALCIFEROL SEMANAL KERN PHARMA 70 MG/2.800 UI COMPRIMIDOS EFG | 82980 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
CIMASCAL D FORTE 1.500 MG/400 UI COMPRIMIDOS MASTICABLES | Laboratorios Farmaceuticos Logogen S.A. | 62796 | COMPRIMIDO MASTICABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
VERISCAL D 1.500 MG/400 UI COMPRIMIDOS MASTICABLES | Laboratorios Farmaceuticos Valomed S.A. | 62442 | COMPRIMIDO MASTICABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
IDEOS UNIDIA 1000 MG/880 UI GRANULADO EFERVESCENTE | 032033019IP | GRANULADO EFERVESCENTE | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
DELTIUS 25.000 UI CAPSULAS DURAS | 84441 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
CALDEOS 1.000 MG/880 UI COMPRIMIDOS MASTICABLES EFG | Procare Health Iberia S.L. | 81859 | COMPRIMIDO MASTICABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
COLECALCIFEROL ROVI 30000 UI COMPRIMIDOS RECUBIERTOS CON PELICULA | 83672 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
ACIDO ALENDRONICO/COLECALCIFEROL SEMANAL ACCORD 70 MG/2800 UI COMPRIMIDOS EFG | 84397 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
DEVIK 25.000 UI/2,5 ML SOLUCION ORAL | 84796 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
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